LYPHOMED's GENERIC CEFAZOLIN IS ONE OF THREE FIRST-TIME ANDA
LYPHOMED's GENERIC CEFAZOLIN IS ONE OF THREE FIRST-TIME ANDA approvals received by the firm on Nov. 17. In addition to cefazolin, (Lilly's Kefzol and SmithKline's Ancef), LyphoMed received ANDA approval for the antibiotic cephapirin (marketed by Bristol as Cefadyl) and the neuroleptic droperidol (marketed by Janssen as Inapsine). LyphoMed is the first company to receive ANDA approval for generic versions of cefazolin and cephapirin in finished dosage forms. Other companies, however, have received approval for the bulk formulations of the first-generation cephalosporins. LyphoMed's Invenex Labs division received approval for cefazolin sodium in a .5 g/10 ml vial, a 1 g/10 ml vial, a .5 g/100 ml piggyback vial, a 1 g/100 ml piggyback vial, and a 10 g pharmacy bulk package. LyphoMed said it will launch cefazolin when the patent expires in mid-1987. The Invenex division received approval for cephapirin sodium in 500 mg/ml vials; 1, 2 and 4 g/100 ml piggyback vials; and 20 g/100 ml pharmacy bulk vials. The company said a launch date has not been set. LyphoMed's droperidol approvals were for 2.5 mg/ml in 2 and 5 ml single-dose vials and, with preservative, in 2 and 10 vials. LyphoMed plans to introduce the neuroleptic in December.
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth